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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN

NCT07498335 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-01

No results posted yet for this study

Summary

A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \<18 years with primary immunoglobulin A nephropathy (IgAN).

Conditions

  • Berger Disease
  • Bergers Disease
  • IgA Nephropathy
  • Immunoglobulin A Nephropathy
  • Primary IgAN
  • Nephritis IgA Type, Nephropathy IgA Type

Interventions

DRUG

Drug: Atrasentan

* 104 Weeks - Film-coated tablet * Other Names: Atrasentan Hydrochloride ABT-627

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-02
Primary Completion
2030-11-29
Completion
2031-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07498335 on ClinicalTrials.gov